MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG LIGHT; SURGICAL MESH

Catalog Number	0117060
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	05/20/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol perfix plug(device#2) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol perfix plug (device #2).An additional emdr was submitted to represent the bard/davol 3dmax (device #1).Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2011:the patient underwent surgery for implant of an unspecified bard/davol 3dmax (device #1) and an unspecified bard/davol perfix plug (device #2).The patient is only making a claim for an adverse patient outcome against the 3dmax (device #1) and the perfix plug (device #2).The attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2011:the patient underwent surgery for implant of an unspecified bard/davol 3dmax(device #1) and an unspecified bard/davol perfix plug(device #2).The patient is only making a claim for an adverse patient outcome against the 3dmax(device #1) and the perfix plug(device #2).The attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿ addendum per additional information provided: (b)(6) 2011 - patient was diagnosed with right inguinal direct hernia thereby underwent open repair with the implant of perfix light plug.Per operative notes, ¿the ilioinguinal nerve was excised.Perfix light plug was inserted and secured with sutures.¿ (note: there is no indication in the medical records provided that the patient was implanted with a 3dmax mesh.) (b)(6) 2014 - patient was diagnosed with right inguinal hernia with incarcerated direct right inguinal hernia thereby underwent open repair with the implant of unknown onlay mesh.Per operative notes, ¿there was significant scar tissue and previous mesh was seen.The onlay mesh was placed and secured with sutures.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol perfix plug(device#2) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name and 510k number.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jan-2011) is considered to be a best estimate.Corrected fields: d1 (brand name), g4 (510k number).This semdr represents the perfix light plug (device #2).An additional semdr was submitted to represent the 3dmax (device #1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PERFIX PLUG LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 8291021
• Report Number: 1213643-2019-00582
• Device Sequence Number: 2462659
• Product Code: FTL
• UDI-Device Identifier: 00801741030956
• UDI-Public: (01)00801741030956(17)160128(10)HUVA0858
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2016
• Device Catalogue Number: 0117060
• Device Lot Number: HUVA0858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 62 KG